Senior Director, Regulatory Affairs – CMC and Lifecycle Management

Novo Nordisk

Senior Director in Regulatory Affairs responsible for compliance and global team leadership in life sciences sector. Ensuring regulatory compliance for innovative treatments across multiple countries.

Posted 4/21/2026full-timeSøborg • 🇩🇰 DenmarkSeniorWebsite

About the role

Key responsibilities & impact

Shape the regulatory future of life-saving medicines
Lead a global organization spanning four departments
Oversee Chemistry, Manufacturing, and Controls (CMC) regulatory activities
Ensure compliance while scaling manufacturing processes
Develop approval strategies for new manufacturing sites
Collaborate with supply chain and manufacturing teams
Lead high-performing teams across multiple regions
Manage negotiations with major regulatory bodies
Ensure seamless transition as products move to large-scale manufacturing

Requirements

What you’ll need

A Master’s degree in Life Sciences, Engineering, or a related field
Minimum 15 years of progressive experience
Significant expertise in regulatory affairs or compliance management
Deep knowledge of international regulatory requirements (FDA, EMA, PMDA, China NMPA)
Strong track record of executing strategies for manufacturing facilities, product transfers, or lifecycle management
The political and strategic agility to navigate complex organizational dynamics
Demonstrated success leading global teams and complex matrix organizations
Exceptional ability to influence senior leadership and build consensus
Proven ability to develop talent, build succession pipelines, and create high-performing teams

Benefits

Comp & perks

Opportunities to learn and develop
Diverse thinking
Shared purpose
Mutual respect

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairscompliance managementmanufacturing processesapproval strategieslifecycle managementinternational regulatory requirementsnegotiationproduct transfersCMC regulatory activities

Soft Skills

leadershipstrategic agilityinfluenceconsensus buildingteam developmentorganizational dynamicscollaborationhigh-performance team management

Certifications

Master’s degree in Life SciencesMaster’s degree in Engineering